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Daptomycin in the Treatment o...

Daptomycin in the Treatment of Subjects With Infective Endocarditis or Bacteremia Due to S. Aureus

Last Updated: 2017-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2002-03-31

Study Completion Date

2005-02-28

Brief Summary

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The purpose of this study is to compare the safety and efficacy of daptomycin, an antibiotic, to standard therapy in subjects who have infective endocarditis or bacteremia due to Staphylococcus aureus (S. aureus).

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Detailed Description

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Even with prompt treatment, Staphylococcus aureus Infective Endocarditis (IE) continues to be associated with significant morbidity and mortality indicating a need for new therapeutic approaches. In vitro, daptomycin is rapidly bactericidal, with concentration-dependent killing, and MIC90 of 0.5 microgram/ml for S. aureus; in clinical studies, daptomycin appears to be well tolerated and can be administered once every 24 hours by i.v. infusion. These characteristics suggest it should be clinically and microbiologically effective in the treatment of serious S. aureus infections, including IE and bacteremia

Comparison: standard of care (Vancomycin or Semi-synthetic Penicillin with adjunct gentamicin)

Conditions

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Bacterial Endocarditis Bacteremia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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daptomycin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Documented S. aureus bacteremia within 2 calendar days of the first dose of study medication

Exclusion Criteria

* Subjects with a creatinine clearance of less than 30 ml/min
* Subjects with pneumonia
* Pregnant, nursing, or lactating
* Documented history of allergy or intolerance to penicillin or vancomycin
* Subjects with osteomyelitis

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers